HB 1109 2022
CODING: Words stricken are deletions; words underlined are additions.
hb1109-00
Page 1 of 2
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
A bill to be entitled 1
An act relating to distributions of compounded human 2
drug products; creating s. 465.41, F.S.; providing 3
legislative intent; requiring the State Surgeon 4
General to sign and become a party to a specified 5
memorandum of understanding on behalf of the 6
Department of Health; providing reporting requirements 7
for certain persons who ship compounded human drug 8
products interstate; providing an effective date. 9
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Be It Enacted by the Legislature of the State of Florida: 11
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Section 1. Section 465.41, Florida Statutes, is created to 13
read: 14
465.41 Distribution of compounded human drug products. — 15
(1) It is the intent of the Legislature to enhance 16
communication and maximize federal and state resources for 17
oversight of compounded drugs produced by traditional pharmacies 18
and to enact an information sharing agreement with the federal 19
Food and Drug Administration as a tool to monitor such drug 20
products. 21
(2) Upon release of the standard Memorandum of 22
Understanding Addressing Certain Distributions of Compounded 23
Human Drug Products, as provided for in s. 503A(b)(3)(i) of the 24
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. s. 353a, the 25
HB 1109 2022
CODING: Words stricken are deletions; words underlined are additions.
hb1109-00
Page 2 of 2
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
State Surgeon General shall sign and become a party to the 26
memorandum on behalf of the department. 27
(3) On an annual basis, and within 90 days after the 28
beginning of the calendar year, all licensed persons who ship 29
compounded human drug products interstate shall report to the 30
National Association of Boards of Pharmacy Information -Sharing 31
Network the information required by the Memorandum of 32
Understanding Addressing Certain Distributions of Compounded 33
Human Drug Products between the department and the United States 34
Food and Drug Administration as provided by the federal Food and 35
Drug Administration. 36
Section 2. This act shall take effect July 1, 2022. 37